FDA Specific Flashcards
21 CFR Part 11 covers what
Electronic Records and Signatures
Amendment requirements for ICH vs. FDA
ICH: all amendments/changes to protocols must be submitted to the IEC/IRB except administrative
FDA: Phase 1 study also any change/amendments that significantly affects safety of subjects, and for Phase 2 & 3 any change that significantly affects the safety of subjects, scope of investigation, or scientific quality is affected: need to go to the IRB/IEC & FDA
Emergency Use Drug vs. Device
Both life-theratening with no time for IRB approval
-For a drug: investigator contacts manufacture & FDA, and submits to the IRB within 5 working days
-If a device does not have an IDE, you can contact the FDA after
-If a device has an IDE, you need the IRB chair before using, then you notify the IRB, FDA, & Sponsor after use
-Prospective reivew is required for continued use
FDA Inspection-3 outcomes
Given an Establishment Inspection Report (EIR)
1. No action Indicated (NAI), no violations
2. Voluntary action indicated (VAI), minor violations corrective action, respond
3. Official Action Indicated (OAI), Warning letters, 483 significant violation, must respond to 483 within 15 working days
FDA vs. Common Rule
FDA says follow guidelines with greater protection (FDA or common rule)
-Key information in the consent is required for the common rule, but FDA says it should be followed even though not in FDA requirements
-The common rule does not require continuing reviews, but the FDA does
Form 3454
Certification of an investigator not having any financial interests (I do not have any financial disclosure)
Form 3455
clinical investigator disclosure of financial interests and arrangements (I do have financial interests to disclose)
Form 3500
Voluntary Reporting of Adverse Events & Product Problems to Medwatch (after product is approved)
* can be used by consumers of drug, food or cosmetic products to report any product errors/defects or AEs that may occur with use
Form 3500A
For use by user-facilities, distributors, and manufactures for mandatory reporting to Medwatch for AEs
Form 482
Notice of Inspection
Form 483
Observations for an FDA inspection
Medwatch
System by which the FDA gathers info on AEs for marketed drugs, biologics, and devices
-VAERS-vaccine
ADEERs-NCI sponsorored
CIOMS-International
Period summary reports go to the FDA
Studies with an IND or IDE (exemption)
must comply with the code of federal regulations, the US Law not ICH
What are 21 CFR Part 11 Subparts A, B and C?
A – General Provisions,
B – Electronic Records,
C – Electronic Signatures
What is a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be legally binding equivalent of handwritten signature?
Electronic Signature
What is a method of verifying an individual’s identity based on measurement of the individual’s physical features or repeatable actions where those features and or actions are both unique to that individual and measurable?
Biometrics
What is an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified?
Digital Signature (more secure than electronic signature as has distinct rules)
What is an environment in which system access is controlled by persons who are responsible for the content of the electronic records that are on that system?
Closed System (more restrictive, less users, requires specific access)
Ex. Florence, Healthlink, Oncore, REDcap
What is an environment in which system access is not controlled by persons who are responsible for the content of the electronic records that are on the system?
Open System (allow anyone to make an account, can introduce compliance issues)
What is the scripted name or legal mark of an individual handwritten by that individual?
Handwritten Signature
